活性薬剤の低濃度測定のための分散および減弱総反射率による量子レーザーカスケード光譜を用いた分析方法の開発
Plata-Enríquez Jl1,2, Puche-Mercado Jf1, Palmer-Velázquez S1
1Center for Chemical Sensors (CC) / Chemical Imaging and Surface Analysis Center (CISAC), Department of Chemistry, University of Puerto Rico-Mayagüez, Mayagüez, PR 00681, USA.
まとめ
量子カスケードレーザー光譜法 (QCLS) は,タブレット製のアセトアミノフェンを正確に定量化します. QCLSを使用した錠剤の活性薬剤の含有量を予測するには,拡散反射反射がより正確です.
科学分野:
- 分析化学
- スペクトロスコーピー
- 薬学分析
背景:
- アセトアミノフェンは広く使用されている活性薬剤 (API) です.
- 製薬剤のAPIの正確な定量化は,品質管理に不可欠です.
- プロセス分析技術 (PAT) は,医薬品製造プロセスを改善することを目的としています.
研究 の 目的:
- 量子カスケードレーザー光譜法 (QCLS) を使用して,低濃度錠剤のアセトアミノフェンを定量化します.
- タブレット分析のための減弱総反射 (ATR) と分散反射反射 (DRB) の有効性を比較する.
- QCLSをPATの 医薬品用ツールとして確立する.
主な方法:
- アセトアミノフェンの濃度が0. 0%から3. 0%までのW/ Wの錠剤は,一般的なエキシピエントで作られました.
- QCLSを使用した中赤外線スペクトル (770〜1890 cm−1) を非接触モードで使用した.
- 減弱された総反射 (ATR) と拡散反射反射 (DRB) のテクニックが使用された.
- 主要成分分析 (PCA) を含む多変量分析が,校正に使用された.
主要な成果:
- QCLSは,アセトアミノフェンの錠剤配合の差別化と定量化に成功しました.
- 拡散反射回転 (DRB) は,錠剤分析のATRと比較して,API含有量を予測するより高い精度を示した.
- 主要成分分析により,アセトアミノフェンの定量化のための校正モデルが効果的に生成されました.
結論:
- QCLSは,薬剤分析のための強力なスペクトル検査技術です.
- DRBは,タブレットのアセトアミノフェンの中赤外線QCLS分析の好ましい方法である.
- QCLSは,リアルタイム製薬品質管理のためのプロセス分析技術 (PAT) に統合する大きな可能性を示しています.
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